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The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis
INTRODUCTION: RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time un...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557042/ https://www.ncbi.nlm.nih.gov/pubmed/36227530 http://dx.doi.org/10.1007/s40744-022-00500-6 |
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author | Alten, Rieke Burmester, Gerd R. Matucci-Cerinic, Marco Salmon, Jean-Hugues Lopez-Romero, Pedro Fakhouri, Walid de la Torre, Inmaculada Zaremba-Pechmann, Liliana Holzkämper, Thorsten Fautrel, Bruno |
author_facet | Alten, Rieke Burmester, Gerd R. Matucci-Cerinic, Marco Salmon, Jean-Hugues Lopez-Romero, Pedro Fakhouri, Walid de la Torre, Inmaculada Zaremba-Pechmann, Liliana Holzkämper, Thorsten Fautrel, Bruno |
author_sort | Alten, Rieke |
collection | PubMed |
description | INTRODUCTION: RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time until discontinuation from any cause (excluding sustained response) of the initial treatment. METHODS: RA-BE-REAL is an ongoing, prospective, observational, 36-month study in patients with RA initiating treatment with baricitinib (cohort A) or any other tsDMARD or any bDMARD (cohort B) for the first time. The primary objective is to assess the time until treatment discontinuation from any cause (excluding sustained response) at 24 months, (i.e., the rate of discontinuation of initial baricitinib or ts/bDMARD). Patient profiles of each cohort are described and compared. Post-baseline data are descriptively analyzed. This manuscript presents baseline and interim (6-month) outcomes for European patients with RA participating in the global RA-BE-REAL study. RESULTS: Data from 1074 patients (cohort A: 509; cohort B: 565) were analyzed. For cohorts A and B, respectively, the 6-month cumulative incidence (95% confidence interval) of treatment discontinuation was 16.5 (12.9–21.1) and 23.3 (19.1–28.2), and the proportions of patients achieving remission were 25.6% and 18.5%. At baseline, mean patient age was 59.1 and 57.0 years (p = 0.010) and mean disease duration was 10.0 and 8.9 years (p = 0.047), respectively. The proportions of patients exposed to ts/bDMARDs at any time before study entry were 51.9% and 39.1%, and the proportions of patients initiated on monotherapy were 50.9% and 31.2%, respectively. CONCLUSION: In real-world settings, patients with RA initiating treatment with baricitinib were older and had longer disease duration than those initiating treatment with any other tsDMARD or any bDMARD. Initial descriptive data regarding treatment discontinuation (including reasons for discontinuation), effectiveness, and treatment patterns will be enriched as the study progresses. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00500-6. |
format | Online Article Text |
id | pubmed-9557042 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-95570422022-10-13 The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis Alten, Rieke Burmester, Gerd R. Matucci-Cerinic, Marco Salmon, Jean-Hugues Lopez-Romero, Pedro Fakhouri, Walid de la Torre, Inmaculada Zaremba-Pechmann, Liliana Holzkämper, Thorsten Fautrel, Bruno Rheumatol Ther Original Research INTRODUCTION: RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time until discontinuation from any cause (excluding sustained response) of the initial treatment. METHODS: RA-BE-REAL is an ongoing, prospective, observational, 36-month study in patients with RA initiating treatment with baricitinib (cohort A) or any other tsDMARD or any bDMARD (cohort B) for the first time. The primary objective is to assess the time until treatment discontinuation from any cause (excluding sustained response) at 24 months, (i.e., the rate of discontinuation of initial baricitinib or ts/bDMARD). Patient profiles of each cohort are described and compared. Post-baseline data are descriptively analyzed. This manuscript presents baseline and interim (6-month) outcomes for European patients with RA participating in the global RA-BE-REAL study. RESULTS: Data from 1074 patients (cohort A: 509; cohort B: 565) were analyzed. For cohorts A and B, respectively, the 6-month cumulative incidence (95% confidence interval) of treatment discontinuation was 16.5 (12.9–21.1) and 23.3 (19.1–28.2), and the proportions of patients achieving remission were 25.6% and 18.5%. At baseline, mean patient age was 59.1 and 57.0 years (p = 0.010) and mean disease duration was 10.0 and 8.9 years (p = 0.047), respectively. The proportions of patients exposed to ts/bDMARDs at any time before study entry were 51.9% and 39.1%, and the proportions of patients initiated on monotherapy were 50.9% and 31.2%, respectively. CONCLUSION: In real-world settings, patients with RA initiating treatment with baricitinib were older and had longer disease duration than those initiating treatment with any other tsDMARD or any bDMARD. Initial descriptive data regarding treatment discontinuation (including reasons for discontinuation), effectiveness, and treatment patterns will be enriched as the study progresses. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00500-6. Springer Healthcare 2022-10-13 /pmc/articles/PMC9557042/ /pubmed/36227530 http://dx.doi.org/10.1007/s40744-022-00500-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Alten, Rieke Burmester, Gerd R. Matucci-Cerinic, Marco Salmon, Jean-Hugues Lopez-Romero, Pedro Fakhouri, Walid de la Torre, Inmaculada Zaremba-Pechmann, Liliana Holzkämper, Thorsten Fautrel, Bruno The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title | The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title_full | The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title_fullStr | The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title_full_unstemmed | The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title_short | The RA-BE-REAL Multinational, Prospective, Observational Study in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic, or Biologic Disease-Modifying Therapies: a 6-Month Interim Analysis |
title_sort | ra-be-real multinational, prospective, observational study in patients with rheumatoid arthritis receiving baricitinib, targeted synthetic, or biologic disease-modifying therapies: a 6-month interim analysis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557042/ https://www.ncbi.nlm.nih.gov/pubmed/36227530 http://dx.doi.org/10.1007/s40744-022-00500-6 |
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